Start-up Associate
Labcorp Drug Development
Bucharest, Romania
3 zile în urmă

Job Overview :

Labcorp drug development is looking to recruit Start Up Specialist in Roamnia

Responsibilities :

  • Collect, track and perform a quality review of all essential & investigator documents required for effective and compliant study site activation and maintenance
  • Ensure that all assigned maintenance and Start-up activities are on track and in accordance with client expectations, ICH / GCP, SOPs, budget, quality and applicable laws and guidelines
  • Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner.
  • With guidance from line manager and experienced colleagues, adapt Informed Consent Forms and other patient facing material to country specific requirements.
  • May support / assist the contract negotiation process under supervision of an experienced colleague or line manager.
  • Escalate study issues appropriately and in a timely fashion.
  • Update study documents when there are changes in study personnel / study amendments.
  • Contribute to the preparation of submissions to IRB / IEC with appropriate supervision.
  • Ensure high quality documents are filed and systems are updated on an ongoing and timely basis making Covance ready for an audit at any time.
  • Undertake tasks delegated by senior team members, depending upon country and situational requirements with proper supervision.
  • Perform other duties as assigned by management.
  • Education / Qualifications :

  • University / College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.
  • g., nursing certification, medical or laboratory technology)

    Experience : Minimum Required :

    Minimum Required :

  • experience with start up activities , or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
  • Working knowledge of ICH, FDA, IRB / IEC and other applicable regulations / guidelines. Demonstrated basic understanding of the clinical trial process
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